Kornimate/medical-research-clean huggingface dataset:
impact of preemptive intravenous ibuprofen on postoperative edema and trismus in the third molar teeth

Conditions: Trismus; Edema

Summary: this study was planned to investigate the antiinflammatory activity of preemptive intravenous ibuprofen on inflammatory complications such as edema and trismus after third molar tooth surgery


Eligibility criteria:
inclusion criteria: * elective 3. molar tooth extraction * patients between the ages of 20-35 * patients who are symptomatic * 3. molar tooth angular or horizontal settled patients exclusion criteria: * patients who refuse to participate in the study * patients under 20 years old, over 35 years old * patients who are allergic to known non-steroidal anti-inflammatory drugs * pregnant patients * patients with severe hepatic insufficiency * patients with severe renal insufficiency

Keywords: preemptive intravenous ibuprofen trismus edema third molar tooth extraction antiinflammatory effect
intermittent fasting for the treatment of type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: to test whether a lifestyle program featuring one of two forms of intermittent fasting (ier or tre) can feasibly and effectively improve glycemia in patients with type 2 diabetes, and potentially induce diabetes remission.

intermittent energy restriction (ier) and time-restricted eating (tre) are two distinct forms of intermittent fasting which have yet to be compared for the treatment of type 2 diabetes. investigators will test whether a comprehensive, intensive lifestyle program featuring each of these intermittent fasting approaches is feasible and effective for improving glycemic control in patients diagnosed with type 2 diabetes within the past 10 years. both interventions will be delivered over one year in three phases: (1) a 12-week weight loss program featuring weekly group meetings, (2) a 12-week weight maintenance program featuring biweekly group meetings, and (3) a 6-month low-contact follow up period featuring monthly check-ins.

Eligibility criteria:
inclusion criteria: 1. diagnosed with type 2 diabetes in the past 10 years. 2. age 21-65 years 3. bmi of 25 - 45 kg/m2 4. hba1c of 6.7-9.5%, or those with a1c of \<6.7% on glucose-lowering medications 5. ability to participate in a graduated physical activity program 6. clearance from study physician. exclusion criteria: 1. inability to attend health education meetings. 2. weight change of \>=5% in the previous 3 months. 3. addition of new antihyperglycemic or weight-reducing medication in the previous 2 months. 4. serious medical risk such as ongoing treatment for cancer, uncontrolled hypertension, recent cardiac event, or other medical condition presenting acute risk of participation in a lifestyle change program. 5. untreated depression or anxiety, or increase in associated medications in the previous 3 months. 6. current participation in another lifestyle change intervention, such as a tobacco cessation program or physical activity program. 7. pregnancy or lactation within the previous six months 8. weight of \>450 lbs 9. currently taking medications that may result in hypoglycemia during fasting and unwilling to stop prior to the study
treatment of pancreatic cancer with abraxane

Conditions: Metastatic Pancreatic Cancer

Summary: this observational program collects data on tolerability, safety and efficacy regarding the use of abraxane in metastatic pancreatic cancer patients in the daily clinical routine. additionally data on dosage that is actually used in these patients will be collected. patients who have pancreatic cancer and additional diseases can be documented in this study, too. collected data might generate learnings on the optimal use of abraxane in the daily routine setting.

this observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of abraxane in its labeled indication in metastatic pancreatic cancer. additionally data on real life dosing in daily clinical routine will be analyzed. a detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy. hands-on experience with nab-paclitaxel is very limited in austria and an non-interventional study could enhance knowledge on optimal drug handling and adverse event management.

Eligibility criteria:
inclusion criteria: 1. metastatic pancreatic carcinoma 2. age \> 18 years 3. signed informed consent 4. normal hepatic, renal and bone marrow functions exclusion criteria: 1. pregnant and lactating females 2. previous treatment for metastatic pancreatic disease 3. known hypersensitivity to nab-paclitaxel 4. neutrophils \< 1,5 x 10\^9/l -

Keywords: metastatic pancreatic cancer nab-paclitaxel gemcitabine non-interventional
double-blind, randomized, single dose escalation safety study of intraarticular bone morphogenic protein (38a bmp-7) in subjects with osteoarthritis (oa) of the knee

Conditions: Osteoarthritis of the Knee

Summary: the objective of the study is to determine the safety and tolerability of two different formulations of bmp-7 for the treatment of osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria * ambulatory with a diagnosis of oa of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days. * \>40 years * radiographic evidence of at least one osteophyte in either knee at screening exclusion criteria * concurrent medical or arthritis condition that could interfere with evaluation of index knee joint (including fibromyalgia) * unwilling to abstain from nsaids and/or other analgesic medications for 48 hrs prior to assessments. subjects can remain on acetaminophen up to 3.0 g daily. * received arthroscopic or open surgery to the index knee within 6 months of screening * history of joint replacement surgery (index knee). * corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening * long acting hyaluronic acid injection of the index knee within 6 months of screening * history of reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, and arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia. * history of malignancy with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ. * female subject with reproductive capability.
preoperative and postoperative sublingual misoprostol for prevention of postpartum blood loss in cesarean section

Conditions: Postpartum Hemorrhage

Summary: cesarean section is one of the most common major surgical operations among women. in 2015, the incidence of cesarean section in woman health hospital in assiut university accounts for 51.3 % of all deliveries


Eligibility criteria:
inclusion criteria: * all pregnant women who will undergo elective lower segment cesarean section * term ( ≥ 37 weeks) * normal fetal heart tracing. exclusion criteria: * placenta previa-rupture uterus * classical cesarean section * preterm delivery * hypertensive disorders of pregnancy * bleeding tendency * previous history of postpartum hemorrhage * concurrent anticoagulant therapy * concurrent long-term use of steroids * fetal distress * antepartum haemorrhage
management of ovarian masses in pediatric patients: an italian survey

Conditions: Ovarian Cysts; Pediatric ALL; Diagnosis

Summary: objectives: the international ovarian tumor analysis (iota) provides a specific terminology for adult ovarian masses, while, currently, there is no systematic classification for preoperative assessment of adnexal lesions in childhood and adolescence. this study aims to survey italian pediatric surgeons to evaluate ovarian masses' management (from diagnosis to treatment) in patients aged 1-18. methods: a 27-question survey was distributed. it consisted of questions regarding the management and use of ultrasound and iota terminology in diagnosing ovarian masses in childhood and adolescence, in emergency regimes and in planned surgeries.

purpose and objectives of the clinical trial the aim of the present study is to propose a survey among italian pediatric surgeons (inside the società italiana di chirurgia pediatrica-sicp) to evaluate the current management of ovarian masses in patients aged 1 -18, in terms of preoperative work up and surgical modalities. experimental design primary objective: to evaluate the current management of ovarian masses in patients aged between 1 and 18. experimental plan: observational study, survey. setting: this is an online survey designed using redcap forms feature. data will be collected in a period of 6 months. the informed consent forms for participation, use of personal data and the link for the questionnaire will be sent by e-mail to all italian pediatric surgeons belonging to the sicp. the surgeons who accept to participate, will return both signed consent forms and a copy of their identity card. the survey is divided into seven sections. * section 1: demographic data. * section 2: data on surgical background of the institution and the pediatric surgeons. * section 3: management of pediatric patients in emergency. * section 4: management of pediatric patients who had planned surgery. * section 5: additional management data. * section 6: knowledge of the iota group and terminology. * section 7: availability to participate in a multi-center retrospective study. questions asked for responses using yes/no, multiple-choice, or short freeform written answers. more than one response could be given for many questions, it is specified. (the detailed description is reported in the attachment 1).

Eligibility criteria:
inclusion criteria: pediatric surgeons who work in public hospitals that have managed or collaborated in the management of pediatric patients affected by ovarian cyst. signed informed consent for participation in the study and for the use of personal data. exclusion criteria no answer and/or non-completion of the questionnaire within 1 month after sending our e-mail.

Keywords: ovarian cysts pediatric patients ultrasound survey
efficacy and safety of first-line art with bic/ftc/taf introduced at the first clinical visit

Conditions: HIV Infections

Summary: bictegravir/emtricitabine/tenofovir alafenamide (bic/ftc/taf) is a recommended first-line antiretroviral regimen. croatia has a centralized care for people living with hiv (plwh) and all persons are seen and treated in a single center, preferably in a same-day initiation model whenever suitable. this retrospective cohort study evaluated antiretroviral therapy (art) naïve plwh who initiated bic/ftc/taf, in a same-day model. the goal of the study is to assess safety and efficacy of this model by collecting information from the electronic database of the croatian hiv reference centre.


Eligibility criteria:
inclusion criteria: * hiv seropositivity confirmed by a fourth generation test * the subject had not previously taken art * art was started within 24 hours of the first examination exclusion criteria: * persons under 18 years of age * people who are pregnant, breastfeeding or planning to become pregnant * unacceptable interaction with a drug that the subject is already taking

Keywords: hiv bictegravir rapid start same-day initiation
molar intrusion in open bite treatment

Conditions: Anterior Open Bite

Summary: this experimental study will evaluate the effect of different methods for the molar intrusion (compared with the control group) in adolescent and adult patients with open bite malocclusion. the study sample will consist of 45 patients with anterior open bite. the sample will be randomly allocated into two experimental groups, in addition to a control group. the investigators will apply a modified version of the open bite appliance (oba), by erverdi and usumez, for all patients in upper posterior teeth. for this purpose, miniplates will be used in the first treatment group, while miniscrews will be used in the second treatment group. in the control group, only oba will be used. the skeletal and dentoalveolar changes occurring after intrusion of posterior teeth will be assessed by using posteroanterior and lateral cephalometric radiographs. pre- and post- treatment changes for each group will be evaluated, in addition to the comparison of the post-treatment skeletal and dental changes that occurs between groups.

open bite malocclusion is considered one of the most difficult orthodontic problems to correct because it appears as a result of the interaction of numerous etiological factors (genetic, dental, skeletal, functional, soft tissue, and habit) that contribute to its development. various therapeutic approaches have been proposed for the treatment of an anterior open bite. these approaches vary depending on the causative factors and involve myotherapy, preventive treatment, functional therapy, orthognathic surgery, and orthodontic treatment using anterior teeth extrusion or posterior teeth intrusion. among the non-surgical orthodontic treatment methods are the temporary anchorage devices (tads) including miniplates and miniscrew or micro-screw implants. the intrusion of posterior teeth with temporary anchorage devices was suggested to lead to decreased lower facial height by a counterclockwise rotation of the mandible; this may resemble the orthognathic surgery outcomes for any open bite patients. to the best of the investigators current knowledge, this is the first randomized controlled trial evaluating the effect of molar intrusion in adolescence and adult patients in the permanent dentition stage.

Eligibility criteria:
inclusion criteria: * patients with skeletal open bite determined by an increased b angle (angle between the maxillary plane and mandibular plane), the sum of bjork and the mandibular plane angle (angle between sn plane and mandibular plane). * patients between 12 and 18 years old in permanent dentition stage. * negative over-bite of more than a mm * class i or class ii skeletal anteroposterior relationship. exclusion criteria: * previous orthodontic treatment. * patients with syndromes, clefts, or craniofacial abnormalities. * class iii skeletal anteroposterior relationship.

Keywords: open bite molar intrusion temporary anchorage devices
10-year follow-up of patients with rheumatoid arthritis who received structured treat-to-target therapy in early disease

Conditions: Rheumatoid Arthritis

Summary: the arctic-forward study is a multi-center prospective observational study investigating the long-term outcomes of rheumatoid arthritis (ra) patients who received structured treat-to-target therapy early in their disease. the main hypothesis of this project is that ra treat-to-target strategies during the first two years of disease result in beneficial long-term outcomes both with regards to joint damage, disease activity and societal costs.

rheumatoid arthritis (ra) is one of the most common autoimmune diseases. recent developments in ra treatment has shown to change the outcome of ra for the early stages of the disease, with very limited loss of work participation and high rates of disease activity remission. the data on the long-term outcome for patients who received early optimal treatment is much more limited, and it is of special clinical interest to know to what extent these patients should be monitored with regards to slowly evolving joint damage, subclinical inflammation, loss of physical function and loss of work participation. the aim of this study is to assess clinical, radiographic and functional long-term outcomes of modern ra care and to identify risk factors for progressive disease.the main hypothesis of this project is that ra treat-to-target strategies during the first two years of disease result in beneficial long-term outcomes both with regards to joint damage, disease activity and societal costs. we will perform an extensive evaluation of all patients participating in the arctic study 10 years after the initiation of structured treat-to-target therapy. outcomes include disease activity, radiographic damage, functional status, dmard use, extra-articular manifestations including interstitial lung disease, comorbidities, survival, work participation, health care resource use, and health related quality of life.

Eligibility criteria:
inclusion criteria: all patients that entered the arctic study are eligible for the follow-up study. the main inclusion criteria in the arctic study were age 18-75 years, fulfilment of the 2010 acr classification criteria for ra, dmard naivety with indication from dmard therapy, and symptom duration of less than two years. exclusion criteria: psychiatric or mental disorders, alcohol abuse, other substance abuse, other factors making adherence to the study protocol impossible

Keywords: long-term outcomes extra-articular manifestations
managing cancer and living meaningfully

Conditions: Mood; Cancer Brain

Summary: the purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, managing cancer and living meaningfully (calm). researchers hope to better understand the potential benefits of this intervention on brain tumor patients' mood and quality of life. this may lead to improvements in doctor's understanding of how to enhance brain tumor patient's wellbeing and overall functioning.

in this study, participants will be asked to do the following things: 1. complete \~15-minute online surveys before the program, immediately after the program (4 months), and at follow-up (6 months). . questions will ask about mood, anxiety, death distress, quality of social relationships, and satisfaction with life. 2. meet with an interventionist six times (biweekly) for individual sessions via zoom, lasting 50-60 minutes each. sessions will be audio-recorded to ensure all participants receive the same information. participants will be asked to only use first names. 3. complete weekly \~5 minute online surveys after each session on satisfaction with the program. 4. complete an exit interview by telephone approximately 1 month after the 6-session intervention. this exit interview will last approximately 15-30 minutes.

Eligibility criteria:
inclusion criteria: * have a confirmed malignant brain cancer diagnosis via histopathology * be a minimum of 2 weeks post-surgical resection or biopsy (if applicable) * be primarily english speaking * be age 18-89 * obtain \>20 on the telephone interview for cognitive status (tics) * have current elevated depression or death anxiety symptoms * have a reliable internet connection to participate in the zoom therapy sessions exclusion criteria: * major communication difficulties as determined by the research team which would prohibit psychotherapeutic interaction * inability to meet with interventionist via an electronic device for telehealth intervention sessions * inability to provide informed consent
clinical study of cldn18.2 pet/ct for noninvasive diagnosis of gastric and pancreatic cancer

Conditions: Positron Emission Tomography; Pancreatic Neoplasms; Igestive System Neoplasms

Summary: in this study, we will investigate the diagnostic efficacy and safety of \[18f\]f-h3resca-3a12 and \[68ga\]ga-nota-3a12 in metastatic gastric and pancreatic cancers, and evaluate the sensitivity and specificity of the use of \[18f\]f-h3resca-3a12 and \[68ga\]ga-nota-3a12 for diagnosing metastatic gastric and pancreatic cancers . this study will provide a new method for the noninvasive target-specific diagnosis of gastric and pancreatic cancer, and provide intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment.


Eligibility criteria:
inclusion criteria: * (1) age between 18 and 65 years old, gender is not limited. (2) patients with gastric or pancreatic cancer confirmed by puncture or surgical pathology. (3) written informed consent signed by the subject or his/her legal guardian or caregiver. (4) willingness and ability to cooperate with all programs of this study. exclusion criteria: - (1) severe hepatic or renal insufficiency; (2) targeted therapy before radiotherapy or pet/ct scan. (3)renal function: serum creatinine less than or equal to the upper limit of the normal range;liver function: bilirubin, ast(sgot)/alt(sgpt) less than or equal to the upper limit of the normal range. (4) history of serious surgery in the last month. (5) those who have participated in other clinical trials during the same period.
the acute effects of interesterification of commercially used fats on postprandial fat metabolism

Conditions: Healthy Adults; Postmenopausal Women

Summary: the purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used commercially versus the corresponding un-interesterified blend.

aim: the current study aims to investigate the acute effects of commercially relevant interesterified 'hardstock' versus the corresponding un-interesterified blend on 8 h postprandial fat metabolism. hypothesis: interesterification of a palm kernel and palm stearin fat blend, to produce a fat with a higher proportion of palmitic acid in the middle position of the triglyceride (tag; but the same fatty acid composition), will alter postprandial lipid metabolism. subjects: participants will include 24 healthy male and female (postmenopausal) volunteers aged between the ages of 45 and 75 years (since during this age metabolic changes start to take place). power calculation: based on previous studies carried out by our group at king's college london, a sample size of 10 males and 10 females is required to detect a (clinically relevant) difference (for males and females separately) between means of 0.3 mmol/l maximal difference in 8 h plasma tag concentration (standard deviation 0.33 mmol/l, significance level (alpha) of 0.05 and 80% power). 12 males and 12 females will be recruited to allow for a 20% drop out rate. expected value:the study will provide novel information on the acute effects of commercially relevant processed fats on postprandial lipaemia.

Eligibility criteria:
inclusion criteria: * males and females aged 45-75 years * healthy (free of diagnosed diseases listed in exclusion criteria) * able to understand the information sheet and willing to comply with study protocol * able to give informed consent exclusion criteria: * medical history of myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes * body mass index \ 35 kg/m2 * plasma cholesterol ≥7.5 mmol/l * plasma triacylglycerol \> 3 mmol/l * plasma glucose \> 7 mmol/l * blood pressure ≥140/90 mmhg * current use of antihypertensive or lipid lowering medications * premenopausal (for women) * alcohol intake exceeding a moderate intake (\> 28 units per week) * current cigarette smoker (or quit withint the last 6 months) * ≥ 20% 10-year risk of cvd as calculated using a risk calculator

Keywords: interesterified postprandial lipid
a long term follow up study of patients who have complete clearance of their actinic keratosis (ak) lesions at the day 57 visit in the pep005-028 study

Conditions: Actinic Keratosis

Summary: this study is designed to follow up patients, who have participated in the pep005-028 study and observed complete clearance of their actinic keratosis (ak) lesions, over a 12 month period to assess both recurrence of ak lesions and long term safety in the selected treatment area.


Eligibility criteria:
inclusion * patient has provided informed consent documented by signing the informed consent form (icf) prior to any study-related procedures * patient achieved complete clearance of ak lesions (lesion count of 0) in the selected treatment area at the day 57 visit in the following peplin ak clinical study: pep005-028 exclusion * concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous peplin ak study) * early termination from study pep005-028

Keywords: peplin actinic keratosis pep005